TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the QT/QTc interval in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec BVBA
• Treatments: Bedaquiline; Diarylquinolines; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, and clinical laboratory tests at screening

• A Body Mass Index of 18.0 to 28.0 kg/m2, extremes included

• Women must be postmenopausal for at least two years, be surgically sterile and must have negative serum pregnancy test at screening

• Non-smoking for at least three months prior to selection.

Exclusion Criteria:

• Infection with Hepatitis A, B, or C virus

• Infection with the human immunodeficiency virus (HIV)

• History of, or any current medical condition which could impact the safety of the participant in the study

• Previously participated in a TMC207 trial or received an investigational drug or vaccine within 60 days before the planned start of treatment

• A positive urine drug test at screening

• Volunteers with a clinically significant ECG abnormality or any other cardiac history (unusual T wave morphology, history of additional risk for Torsade de Pointes, electrolyte abnormalities, blood pressure outside of the normal range, or history of a clinically relevant heart rhythm disturbance or with a family history of Long QT Syndrome)